MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI; PATIENT SIDE CART

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure to Anastomose (1028); Arrhythmia (1721); Pneumonia (2011)

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the root cause of the reported incidents cannot be determined or is unknown.There was no report or allegation from the customer of a deficiency of the davinci system, instrumentation, or accessories associated with the reported incident.Therefore, there are no products expected for return to intuitive surgical, inc.(isi) for failure analysis evaluation.Isi has attempted to follow-up to gather additional information.However, as of the date of this report, no new information has been obtained.If additional information is received, a follow-up mdr will be submitted.Unable to conduct system or instrument log review due to lack of site, system, procedure, and instrument detail.While procedure images were provided within the article showing a description of the surgical technique for robotic-assisted ivor lewis minimally invasive esophagectomy (ramie ivor lewis), there was no image or video clip supplied for review related to a specific event.While there is limited information about each reportable event in order to provide a complete report for each event, and there is no specific allegation to investigate, the event meets the criteria of a reportable adverse event as it was alleged within the clinical article that there were various complications for which some were described as requiring medical intervention.At this time, the root cause of the issues are unknown.Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Multiple product information are unknown due to limited product information being provided.Due to lack of product information, (510k no.), and (mfg date) are not available.The product is not implantable.It is unknown if the initial reporter submitted a report to the fda.

Event Description

On 30-aug-2021, intuitive surgical, inc.(isi) became aware of a clinical study article, via an isi clinical journal review, from the updates in surgery article titled, ¿robotic-assisted ivor lewis esophagectomy, a review of the technique¿ (chouliaras, k., hochwald, s., et al., 2021).Within the journal article, operative complications involving da vinci surgical procedures were noted: "two (3.9%) patients developed arrhythmias postoperatively, four (7.9%) developed pneumonia postoperatively and one (2%) required reintubation.There were two anastomotic leaks (3.9%), one required endoscopic clips and one was managed with bowel rest, jejunal tube feeds and antibiotics alone." isi has reached out to the author to obtain additional information but has not yet received a response.

Manufacturer Narrative

D15 - intuitive surgical, inc.(isi) received additional information from the article author, a physician, as follows: ¿this is not related to da vinci directly more of a procedure related issue¿.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: DA VINCI
• Type of Device: PATIENT SIDE CART
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• MDR Report Key: 12516668
• MDR Text Key: 273312183
• Report Number: 2955842-2021-11173
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES